single-dose pharmacokinetics and relative bioavailability of two different formulations of opicapone

Conditions: Parkinson Disease

Summary: single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. the study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more.

single-centre, open-label, randomised, two-way crossover study in 28 healthy volunteers. the study consisted of two consecutive single-dose treatment periods separated by a washout period of 14 days or more. a total of twenty-eight (28) healthy volunteers received a single dose of 50 mg opc, orally.

Eligibility criteria:
inclusion criteria: * a signed and dated informed consent form (icf) before any study-specific screening procedure was performed, * male or female subjects aged 18 to 45 years, inclusive, * body mass index (bmi) between 19 and 30 kg/m2, * healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ecg), * negative tests for hepatitis b surface antigen (hbsag), anti-hepatitis c virus (hcv) antibodies and anti-human immunodeficiency virus (hiv) antibodies at screening, * clinical laboratory test results clinically acceptable at screening and on d-1 of each treatment period, * negative screen for alcohol and drugs of abuse at screening and on d-1 of each treatment period, * non-smokers or ex-smokers for at least 3 months, * volunteer able to participate, and willing to give written informed consent and comply with the study restrictions, if female: * was not of childbearing potential by reason of surgery or, if of childbearing potential, uses an effective non-hormonal method of contraception (intrauterine device or intrauterine system; condom or occlusive cap \[diaphragm or cervical or vault caps\] with spermicidal foam or gel or film or cream or suppository; true abstinence; or vasectomized male partner, provided that he was the sole partner of that subject) for the entire duration of the study, * negative serum pregnancy test at screening and a negative urine pregnancy test on d-1 of each treatment period. exclusion criteria: * any clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders, or had a clinically relevant surgical history, * any clinically relevant abnormality in the coagulation tests, * any clinically relevant abnormality in the liver function tests, * history of relevant atopy or drug hypersensitivity, * history of alcoholism and/or drug abuse, * current consumption of more than 14 units of alcohol per week \[1 unit of alcohol = 280 ml beer (3-4°) = 100 ml wine (10-12°) = 30 ml spirits (40°)\], * any significant infection or known inflammatory process on screening or admission to each treatment period, * any acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period, * use of medicines within 2 weeks of admission to first period that could affect the subject's safety or other study assessments, in the investigator's opinion, * previously received opicapone, * involvement in other clinical trials of any type within 90 days prior to screening, * participation in more than 2 clinical trials within the 12 months prior to screening, * blood donation or received any blood transfusion or any blood products within the 3 months prior to screening, * vegetarian, vegan or had medical dietary restrictions, * subject not able to communicate reliably with the investigator, * subjects who were unlikely to co-operate with the requirements of the study, * subjects who were unwilling or unable to give written informed consent, if female: * pregnant or breast-feeding, * if of childbearing potential, a positive serum pregnancy test, * volunteer who did not use an accepted effective contraceptive method or used oral contraceptives,